A Randomised Controlled Trial of Artemether-Lumefantrine Versus Artesunate for Uncomplicated Plasmodium falciparum Treatment in Pregnancy
2008

Comparing Treatments for Malaria in Pregnant Women

Sample size: 253 publication 10 minutes Evidence: moderate

Author Information

Author(s): Rose McGready, Saw Oo Tan, Ashley Elizabeth A, Pimanpanarak Mupawjay, Viladpai-nguen Jacher, Phaiphun Lucy, Wüstefeld Katja, Barends Marion, Laochan Natthapon, Keereecharoen Lily, Lindegardh Niklas, Pratap Singhasivanon, White Nicholas J, François Nosten

Primary Institution: Shoklo Malaria Research Unit (SMRU), Mae Sot, Tak, Thailand

Hypothesis

The AL regimen would be superior to AS7 in terms of parasitological efficacy in treating uncomplicated P. falciparum malaria in the second and third trimesters of pregnancy.

Conclusion

The artemether-lumefantrine regimen was safe but less effective than artesunate monotherapy for treating malaria in pregnant women.

Supporting Evidence

  • Both treatments were well tolerated with few side effects.
  • Cure rates for AS7 were significantly higher than for AL.
  • Low drug concentrations in later pregnancy likely contributed to reduced efficacy of AL.
  • Infant health outcomes were similar between the two treatment groups.
  • One-third of recrudescent infections occurred after 42 days of follow-up.

Takeaway

This study looked at two treatments for malaria in pregnant women and found that one treatment worked better than the other.

Methodology

An open-label randomized controlled trial comparing artemether-lumefantrine and artesunate in pregnant women with uncomplicated malaria.

Potential Biases

Potential bias due to the open-label design and lack of blinding.

Limitations

The study was not blinded, which may have influenced the results.

Participant Demographics

Karen women in the second and third trimesters of pregnancy.

Statistical Information

P-Value

0.031

Confidence Interval

95% CI 82.3%–96.1% for AS7 and 95% CI 74.8%–89.3% for AL

Statistical Significance

p=0.031

Digital Object Identifier (DOI)

10.1371/journal.pmed.0050253

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